Recall Z-0207-2018 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
| Date | May 31, 2017 |
| Status | Terminated |
| Reason | Hub damage resulting in breakage and/or leakage during use. |
| Root cause | Process control |
| Action | On May 31, 2017 BD distributed Urgent Medical Device Recall notices and Business Response Cards to their customers. Customers were advised to immediately review their inventory for the specific Catalog (Ref) and lot number, discontinue use of and quarantine the affected item. Complete and return the Business Response Card form via fax to BD 855-544-4803 or email the form to bd4354@stericycle.com. Return all affected products with the completed Business Response Card form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue produ |
| Quantity | 2,598,000 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET Bd, Jul 19, 2002 |